You must include only one of each of the following types of documents for original submission of Complete trials:
Protocol document (complete protocol)
IRB Approval
Informed consent and participating site documents are optional and can be uploaded if relevant information is not included in the Protocol document.
You must include only one each of the following types of documents for each submission of trial amendments:
IRB approval
Informed consent
Protocol highlight change
Participating site documents (if appropriate)
Amended protocol and/or Change memo (summary of changes to the protocol)
You are required to supply your documents as Microsoft Word, Adobe PDF, Microsoft Excel, or WordPerfect files.
Adding Documents
How to Add Trial-Related Documents
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
On the Administrative Data menu, click Trial Related Documents.
The Trial Related Documents page appears.
Click Add.
The Add/Edit Document page appears.
In the Document Type field, select the type of trial document you want to add to the abstract from the drop-down list. Valid document types are as follows:
- Protocol
- IRB approval
- Participating Sites
- Informed Consent
- Other
- Change Memo Document
- Protocol Highlighted Document
Click Browse, navigate to the document you want to upload in the File Upload window, and then click Open.
Depending on your operating system, the File Upload window and the Open button may be named something else.
The Trial Related documents page displays your new document in the table.
Editing and Replacing Documents
You can edit current trial-related documents by downloading them, editing them, and replacing them.
To delete, rather than edit, documents other than protocol and IRB approval documents, see Deleting Documents.
How to Edit and Replace Trial-Related Documents
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
On the Administrative Data menu, click Trial Related Documents.
The Trial-Related Documents page appears.
To replace a document, click the Edit icon and upload a replacement document as per the instructions below. The replacement document must be of the same type as the original.
The document is replaced and appears in the table. Continue with the steps below only if you want to modify an existing file.
To edit a document, click its file name link, save the file to a location on your local drive, and modify the file as necessary. You can save the modified file with the same name (that is, write over the original), or save it with a new file name.
On the Trial Related Documents page, click the Edit icon in the row of the document you downloaded.
The Add/Edit Document page appears. Note that you are not able to change the document type.
Click Browse, navigate to the document you just edited, and then click Open. Follow your browser/operating system instructions to view or save the document
The Trial Related documents page displays your modified document in the table.
Deleting Documents
You can delete a sub-set of current trial-related documents. Although you can not delete Protocol or IRB Approval documents, you can replace them. See Editing and Replacing Documents.
How to Delete Trial-Related Documents
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
On the Administrative Data menu, click Trial Related Documents.
The Trial Related Documents page appears.
Select the Delete check box for each document you want to delete, or, click Select All to select all documents that are candidates for deletion.
Check boxes are available only for those document types that can be deleted according to the constraints listed at the top of this page.
Click Delete.
On the confirmation pop-up window, click OK to remove the selected document(s) from the trial.
Enter the reason for deleting the document(s), for example, “Duplicate document” in the text box. The system counts down the character count as you type. The character limit is 200.
Click Done.
